An interventional study of Unified Protocol for Anxiety Disorders and Client-centered Supportive Therapy in Anxiety Disorders, Social Anxiety Disorder and Generalized Anxiety Disorder, sponsored by Ibn Haldun University. Recruiting at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Ibn Haldun University · Not applicable, Interventional, and Treatment
The transdiagnostic approach argues that the common features are needed to be taken into account [e.g. distress intolerance (DI), intolerance of uncertainty (IU), worry)] underlying emotional disorders rather than evaluating them separately due to the fact that the dissection of anxiety disorders has increased with each emerging version of the Diagnostic and Statistical Manual of Mental Disorders (DSM), in which the classification of anxiety disorders resulted in an increased number of intervention protocols for each disorder. This also caused an increase of comorbidity among anxiety disorders. Transdiagnostic approach offers a unified protocol (UP) for strengthening the common features, and thereby both preventing the emergence of emotional disorders or intervening the symptom severity of emotional disorders, which can be applied to different types of emotional disorders. The main aim of this study is to develop a UP which is planned to be applied as a group therapy. The UP will include interventions developing the levels of common transdiagnostic features (DI, IU and worry). The study's second aim is to investigate the effect of the developed UP on DI, IU and worry. The third one is to search the effect of the developed UP on symptom severity levels of anxiety disorders. Fourthly, this study will search if the levels of transdiagnostic common features (DI, IU and worry) will predict the levels of symptom severity of anxiety disorders'.
The transdiagnostic approach argues that common features are needed to be taken into account [e.g. distress intolerance (DI), intolerance of uncertainty (IU), worry] underlying emotional disorders rather than evaluating them separately since the dissection of anxiety disorders has increased with each emerging version of the Diagnostic and Statistical Manual of Mental Disorders (DSM), in which the classification of anxiety disorders resulted in an increased number of intervention protocols for each disorder. That is why an increase in comorbidity among anxiety disorders is observed. The transdiagnostic approach offers a unified protocol (UP) for strengthening the common features, thereby preventing the emergence and intervening in several emotional disorders.
As part of dissertation, the main aim of this study is to develop UP in Turkish, and measure the effectiveness of the UP on anxiety disorders and the transdiagnostic features. The UP is planned in group therapy format and includes interventions strengthening the common transdiagnostic features (DI, IU, and worry). This protocol is based on cognitive behavioral therapy (CBT) model. The sessions in the protocol are planned as follows:
Session 1 is assessment session and Session 2 is on psychoeducation, which mainly intend to introduce the CBT model. In session 3, emotions are discussed, revealing that emotions point out what is important for us in life. In session 4, 5 and 6, thoughts are worked on. The participants learn to deal with worry and to challenge unfunctional thoughts and generate alternative explanations. Session 7 focuses on behaviors, in which the role of behaviors and the things that can/cannot be controlled are discussed. Session 8 includes a review of what has been learnt during the group therapy and an evaluation on maintaining the accomplishments. In addition, a follow-up session is planned after one month.
In this study, there will be an intervention (UP) group and a control group. The participants will be assigned to the groups randomly. The measurements are the Distress Intolerance Scale (DTS), Intolerance of Uncertainty Scale-12 (IUS-12), Penn State Worry Questionnaire (PSWQ), Metacognitions Questionnaire-30 (MCQ-30), Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder Assessment (GAD-7).
The uniqueness of this protocol is to be the first UP in Turkish with its own order. It is expected to promote transdiagnostic studies in Turkey. This research is also important in contributing to the literature on transdiagnostic studies, which offer an alternative to comorbidity and a decrease in the symptom severity of anxiety disorders.
7,201 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.
This study's planned enrollment of 60 is below the median of 80 across 6,057 interventional studies indexed under Anxiety Disorders.
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Exclusion Criteria:
The intervention group will receive the transdiagnostic unified protocol (UP) for anxiety disorders that is developed in this study. The UP is based on CBT model and will last for 8 weeks and there will be a follow-up session after one month. Each session will last 1 and a half hours. The pre-, post- and follow-up tests will be given to them to test the effectiveness of the UP.
Other: Unified Protocol for Anxiety Disorders
The supportive therapy group will also last for 8 weeks and there will be a follow-up session after one month. Each session will last 1 and a half hours. The pre-, post- and follow-up tests will be given to them, too.
Other: Client-centered Supportive Therapy
The UP is planned in group therapy format and includes interventions on common transdiagnostic features. The sessions in the protocol are planned as follows: Session 1 - Assessment: introduction, talking on group rules and the process, setting goals Session 2 - Psychoeducation: the CBT model is introduced. Session 3 - Emotions: the role of emotions are discussed. Session 4, 5 \& 6 - Thoughts: the role of thoughts is mentioned. The participants learn to challenge unfunctional thoughts and generate alternative explanations. Also, exercises on excessive worry are applied. Session 7 - Behaviors: the role of behaviors and the things that can/cannot be controlled are discussed. Session 8 - Evaluation \& Maintaining Accomplishments: includes a review of what has been learnt during the group therapy and an evaluation on maintaining the accomplishments. Session 9 - Follow-up session: one month later.
Client-entered therapy provides a non-directive supportive environment for the participants, that includes reflective listening and nonjudgmental and empathic communication. In this group, no CBT intervention will be applied. Through the supportive and non-directive environment, only the effect of relationship will be investigated as a common factor in psychotherapy.
Anxiety
Generalized Anxiety Disorder-7 (GAD-7) scale will be used to measure anxiety level. GAD-7 is a self-report scale consisting of 7 items. It is a 4-point Likert type scale. Items are scored between 0 (Not at all) and 3 (Nearly every day). Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety. In the total score, the cut-off score for GAD diagnosis is 10.
Time frame: pre-test (baseline at Week 1), post-test (at Week 8), follow-up test (1 month after post-test)
Distress Tolerance
Distress Tolerance Scale (DTS) scale will be used to measure distress tolerance level. DTS consists of a total of 15 items. Each item is rated on a 5-point Likert scale range from 1 (Strongly disagree) to 5 (Strongly disagree). A low total score indicates low distress tolerance level.
Time frame: pre-test (baseline at Week 1), post-test (at Week 8), follow-up test (1 month after post-test)
Intolerance of Uncertainty
Intolerance of Uncertainty Scale (IUS) - Short Version will be used to measure the level of intolerance of uncertainty. IUS-12 is a self-report scale consisting of 12 items in total. It is a 5-point Likert scale. Each item is scored between 1 (not at all characteristic of me) to 5 (entirely characteristic of me). A high total score indicates a high level of intolerance to uncertainty.
Time frame: pre-test (baseline at Week 1), post-test (at Week 8), follow-up test (1 month after post-test)
Worry
Penn State Worry Questionnaire will be used to measure the level of worry. PSWQ is a self-report scale with a 5-point Likert-type, consisting of a total of 16 items. Scale items are scored between 1 (Not at all typical) - 5 (Very typical of me). An increase in the PSWQ total score indicates a high level of worry.
Time frame: pre-test (baseline at Week 1), post-test (at Week 8), follow-up test (1 month after post-test)
Metacognition
Metacognition Questionnaire-30 Short Form will be used to measure metacognitive beliefs. MCQ-30, consisting of a total of 30 items, has a 4-point Likert-type scale. Each item is scored between 1 (Do not agree) and 4 (Agree very much). An increase in scale scores indicates an increase in pathological metacognitive activity.
Time frame: pre-test (baseline at Week 1), post-test (at Week 8), follow-up test (1 month after post-test)
Depression
Patient Health Questionnaire-9 (PHQ-9) will be used to measure the level of depression. PHQ-9 consists of 9 questions which is a 4-point Likert type scale. Each item is scored between 0 (Not at all) - 3 (Nearly every day). As the total score increases, the severity of depression increases.
Time frame: pre-test (baseline at Week 1), post-test (at Week 8), follow-up test (1 month after post-test)
Plan to share: No — There is no plan to share because of the ethical concerns of the participants' privacy.
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